Pregnancy Risk Assessment Monitoring System (PRAMS)

Forms and Documents

Document Name	Status
PRAMS Stillbirth Survey Form and Instruction	Unchanged
PRAMS Field Test Form and Instruction	Unchanged
PRAMS Opioid Call-back Surveys Form and Instruction	Unchanged
PRAMS Supplemental Modules Form and Instruction	Unchanged
PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) Form and Instruction	Unchanged
0920-1273 Change Request Justification_6_07_21.docx Justification for No Material/Nonsubstantive Change	2021-06-22
PRAMS SS-B_10_21_19_clean.docx Supporting Statement B	2019-11-04
PRAMS SS-A_11_4_19v2_clean.docx Supporting Statement A	2019-11-04
Att 17-Field Testing Methodology.docx Supplementary Document	2019-06-20
Att 16-Opioid Call-Back Survey Alternate Methods.docx Supplementary Document	2019-06-20
Att 15-PRAMS Live Birth Sample Size by Jurisdiction.xlsx Supplementary Document	2019-06-20
Att 14-PRAMS IRB approval_19.docx Supplementary Document	2019-06-20
Att 5-PIDS Privacy Impact Assessment.pdf Supplementary Document	2019-06-20
Att 4-PRAMS Response Incentives and Rewards by State_rev_080118.docx Supplementary Document	2019-06-20
Att 3-PRAMS Questionnaire Development Process.docx Supplementary Document	2019-06-20
Att 2b_Response to Public Comments on 60 Day FRN.pdf Supplementary Document	2019-06-20
Att 2a-Published 60 Day FRN.pdf Supplementary Document	2019-06-20
Att 1c-PREEMIE ACT.pdf Supplementary Document	2019-06-20
Att 1b-SMART ACT.pdf Supplementary Document	2019-06-20
Att 1a-Section 301 of the Public Health Service Act (42 U.S.C. 241).docx Supplementary Document	2019-06-20

IC Document Collections

IC ID	Document Title	Status
236591	PRAMS Stillbirth Survey Form and Instruction	Unchanged
236590	PRAMS Field Test Form and Instruction	Unchanged
236589	PRAMS Opioid Call-back Surveys Form and Instruction	Unchanged
236588	PRAMS Supplemental Modules Form and Instruction	Unchanged
236587	PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules) Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1273	ICR Reference No: 202106-0920-014
Status: Received in OIRA	Previous ICR Reference No: 201910-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-21FU
Title: Pregnancy Risk Assessment Monitoring System (PRAMS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/22/2021

	Requested	Previously Approved
Expiration Date	11/30/2022	11/30/2022
Responses	117,594	117,594
Time Burden (Hours)	29,766	29,766
Cost Burden (Dollars)	730,438	730,438

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Abstract: The Pregnancy Risk Assessment Monitoring System (PRAMS) collects state-, territory-, and tribal-specific information on maternal experiences and behaviors that occur before, during and shortly after pregnancy. Self-reported survey data are collected by mixed mode methods (mailing, telephone calls). Data collection procedures and instruments are standardized to allow comparison across jurisdictions. The proposed supplemental module is found in the appended document (Appendix A). Suggested minor modifications to previously approved OMB questions from other surveys are noted. The minor changes are to ensure similar formatting to the existing PRAMS survey to which the questions will be appended, eliminations of some response options to reduce question length, and rephrasing of some introductory statements for consistency across the module.

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Authorizing Statute(s): PL: Pub.L. 109 - 450 3 Name of Law: PREEMIE Act
   US Code: 42 USC 301 Name of Law: Public Health Service Act: Research and Investigations
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 44630	08/31/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 28817	06/20/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
PRAMS Field Test	n/a	PRAMS Field Testing
PRAMS Opioid Call-back Surveys	n/a, n/a	PRAMS Opioid Call-back Survey (English) ,   PRAMS Opioid Call-back Survey (Spanish)
PRAMS Phase 8 Questionnaire (Core Questions plus State-selected Standard Modules)	n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a	PRAMS Livebirth Core Phase 8 Mail Questionnaire (English) ,   PRAMS Livebirth Core Phase 8 Mail Questionnaire (Spanish) ,   PRAMS Livebirth Core Phase 8 Phone Questionnaire (English) ,   PRAMS Livebirth Core Phase 8 Phone Questionnaire (Spanish) ,   PRAMS Livebirth Standard Phase 8 Mail Modules (English) ,   PRAMS Livebirth Standard Phase 8 Mail Modules (Spanish) ,   PRAMS Livebirth Standard Phase 8 Phone Modules (English) ,   PRAMS Livebirth Standard Phase 8 Phone Modules (Spanish)
PRAMS Stillbirth Survey	n/a, n/a, n/a, n/a	PRAMS Stillbirth Mail Questionnaire (English) ,   PRAMS Stillbirth Mail Questionnaire (Spanish) ,   PRAMS Stillbirth Phone Questionnaire (English) ,   PRAMS Stillbirth Phone Questionnaire (Spanish)
PRAMS Supplemental Modules	n/a, n/a, n/a	Family History of Breast and Ovarian Cancer Supplement ,   Prescription and Illicit Opioid Use Supplement ,   Disabilities Supplement

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	117,594	117,594	0	0	0	0
Annual Time Burden (Hours)	29,766	29,766	0	0	0	0
Annual Cost Burden (Dollars)	730,438	730,438	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $7,025,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/22/2021

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